# FDA recall Z-0904-2025

> **ev3 Inc** · Class II · device recall initiated 2024-12-10.

## Product

Medtronic NanoCross Elite PTA catheter,   REF numbers amd sizes:    1) AB14W050020090, Size:   5MM X 20MM X 90CM;   2) AB14W050020150, Size:   5MM X 20MM X 150CM;   3) AB14W050040090, Size:   5MM X 40MM X 90CM;   4) AB14W050040150, Size:   5MM X 40MM X 150CM;   5) AB14W050060150, Size:   5MM X 60MM X 150CM;   6) AB14W050080090, Size:   5MM X 80MM X 90CM;   7) AB14W050080150, Size:   5MM X 80MM X 150CM;   8) AB14W050100150, Size:   5MM X 100MM X 150CM;   9) AB14W050120150, Size:   5MM X 120MM X 150CM;   10) AB14W050150150, Size:   5MM X 150MM X 150CM;   11) AB14W050200090, Size:   5MM X 200MM X 90CM;   12) AB14W050200150, Size:   5MM X 200MM X 150CM;   13) AB14W060040090, Size:   6MM X 40MM X 90CM;   14) AB14W060040150, Size:   6MM X 40MM X 150CM;   15) AB14W060060150, Size:   6MM X 60MM X 150CM;   16) AB14W060080150, Size:   6MM X 80MM X 150CM;   17) AB14W060100150, Size:   6MM X 100MM X 150CM;   18) AB14W060120150, Size:   6MM X 120MM X 150CM;   19) AB14W060150150, Size:   6MM X 150MM

## Reason for recall

There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.

## Distribution

Worldwide distribution - US (& PR) Nationwide and the countries of Chile, Cyprus, Estonia, Germany, Italy, Japan, Jordan, Puerto Rico, Spain, United States, Uzbekistan, and Yemen.

## Key facts

- **Recall number:** Z-0904-2025
- **Recalling firm:** ev3 Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-10
- **Report date:** 2025-01-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plymouth, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0904-2025

## Citation

> AI Analytics. FDA recall Z-0904-2025. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/Z-0904-2025. Source: US FDA. Licensed CC0.

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